Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial

This study has been completed.
Sponsor:
Collaborators:
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT00717756
First received: July 15, 2008
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

This study will determine whether lenalidomide has activity in patients with advanced liver cancer that have had growth of their cancer after sorafenib.


Condition Intervention Phase
Liver Cancer
Drug: lenalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Response Rate by Recist Criteria [ Time Frame: on average about every 2 months until progression, on average about 4 months. ] [ Designated as safety issue: No ]

    radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD

    It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed.



Enrollment: 41
Study Start Date: January 2009
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide Drug: lenalidomide
25 mg po qd x 21 days then 1 week off equals one cycle
Other Name: revlimid

Detailed Description:

This study will determine the response rate and toxicities of lenalidomide as second line treatment for patients with liver cancer who have progressed after sorafenib.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically confirmed HCC or triple phase CT consistent with HCC in a patient with known cirrhosis and AFP > 200 ng/ml.
  2. Disease not amenable to curative surgical resection
  3. Patients must have been previously treated with sorafenib. Patients who are unable to receive sorafenib due to financial reasons are also eligible.
  4. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
  5. No previous thalidomide.
  6. Patients must have radiologically assessable tumor.
  7. ECOG performance status of 0-2 at study entry.
  8. Understand and voluntarily sign an informed consent form.
  9. Age >18 years at the time of signing the informed consent form.
  10. Able to adhere to the study visit schedule and other protocol requirements.
  11. Laboratory test results within these ranges:

    • Absolute neutrophil count > 1000/mm3
    • Platelet count > 60,000/mm3
    • Serum creatinine > 2.0 mg/dL
    • Total bilirubin > 4 mg/dL
    • AST (SGOT) and ALT (SGPT) > 5 x ULN.
  12. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix: H Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix: F Education and Counseling Guidance Document
  13. Disease free of prior malignancies for > 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
  3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  4. Use of any other experimental drug or therapy within 28 days of baseline.
  5. Known hypersensitivity to thalidomide.
  6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  7. Any prior use of lenalidomide.
  8. Concurrent use of other anti-cancer agents or treatments.
  9. Known positive for HIV. (The effect of immune modulation of lenalidomide on patients who are HIV positive is unknown).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717756

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Rhode Island
Memorial Hospital of Rhode island
Pawtucket, Rhode Island, United States, 02860
Lifespan Hospitals
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Investigators
Principal Investigator: Howard Safran, MD Brown University
  More Information

Publications:
Responsible Party: howard safran, Principle Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00717756     History of Changes
Other Study ID Numbers: BrUOG-HC-212, Celgene # RV-HCC-PI- 0159, celgene
Study First Received: July 15, 2008
Results First Received: February 20, 2014
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Brown University:
liver cancer, second line

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 16, 2014